The Effects of Nutritional Supplementation and Drug Abuse on HIV

NCT ID: NCT00149656

Last Updated: 2013-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.

Detailed Description

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Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana.

This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.

Conditions

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HIV Infections Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo pill

2

Multivitamins

Group Type EXPERIMENTAL

Multivitamins

Intervention Type DIETARY_SUPPLEMENT

dietary supplement of multivitamins

3

Multivitamins with Selenium

Group Type EXPERIMENTAL

Multivitamins

Intervention Type DIETARY_SUPPLEMENT

dietary supplement of multivitamins

Selenium

Intervention Type DIETARY_SUPPLEMENT

dietary supplement of selenium only

4

Selenium

Group Type EXPERIMENTAL

Selenium

Intervention Type DIETARY_SUPPLEMENT

dietary supplement of selenium only

Interventions

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Multivitamins

dietary supplement of multivitamins

Intervention Type DIETARY_SUPPLEMENT

Selenium

dietary supplement of selenium only

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo pill

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV infected
* CD4 count greater than 350 cells/mm3
* Identified from the Infectious Disease Care Clinic
* Body mass index greater than 18 for women and greater than 18.5 for men

Exclusion Criteria

* Current AIDS-defining condition
* Currently participating in another clinical trial
* Pregnant or intends to become pregnant during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianna K. Baum, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

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Princess Marina Hospital

Gaborone, , Botswana

Site Status

Countries

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Botswana

Other Identifiers

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R01DA016551

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-16551-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-16551-1

Identifier Type: -

Identifier Source: org_study_id

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